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Manager, Operations

at Merck in Millsboro, Delaware, United States

Job Description

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Our Company’s Animal Health (AH) is a BioTechnology Center of Excellence that performs vaccine production operations from antigen production through formulation, filling and packaging. With expertise in mammalian, insect and avian cell culture production (anchorage & non-anchorage dependent), live bird vaccine production, embryonated egg vaccine production, roller bottle vaccine production, bioreactor vaccine production and down-stream processing (water in oil emulsions, aseptic filling, lyophilization, etc.), the Millsboro site supplies and supports products for a wide range of species including poultry, equine, swine, bovine and companion animal.

Position Responsibilities

+ Supervision of facilities, equipment and personnel in the Filling and Freeze Drying department, including coordination of additional labor, such as temporary employees or other departments

+ Participate and support the Safe by Choice programs at the site. Lead safety by example

+ Responsible for preparing and approving formulations for finished products

+ Supervision of aseptic procedures including media preparation, antigen inoculation and harvest, tissue culture preparation and harvest, filling vaccines, etc.

+ Antigen storage and sampling for testing

+ Review and revise processes and procedures against corporate and regulatory requirements to insure compliance

+ Review production records for completeness and compliance to departmental and/or Site SOPs

+ Provide training to personnel to stay current with all regulatory agencies and corporate policies

+ Evaluate personnel and machinery requirements and make and/or implement recommendations for changes and improvements

+ Participation in daily activities to understand requirements and issues

+ Provide guidance to personnel to maximize through-put while meeting regulatory requirements

+ Coordination with venders to determine equipment options

+ Assist in the procurement and installation of new equipment

+ Provide effective solutions to projects with a high level of technical difficulties and internal constraints

+ Scheduling and planning for department requirements

+ Coordinate with Media, Blend, Filling, Central Services, Packaging and Planning personnel to maximize utilization of resources

+ Coordinate resources between areas of production utilizing our Tier process to meet scheduling requirements

+ Provide training, coordinate problem solving issues with Third Party

+ Communicate and track critical component issues and work with venders for resolution

+ Ensure proper safety procedures, standard operation procedures and aseptic techniques are followed

+ Review current practices and ensure employees meet or exceed current procedures and techniques

+ Coordinate SAP and data base entry and the movement of finished goods and in-process products between facilities

+ Including inventory movement and production key performance indicators

+ Other duties as assigned, such as scheduling equipment maintenance, various trouble shooting and contribute as needed on cross-functional teams

+ Participate in KATA’s and KAIZEN’s for our continuous improvement program

+ Lead Tier 1 communication meetings and provide input into Tier 2 and Tier 4 level meetings

Education Requirement

+ High School diploma or equivalent with six (6) years of relevant leadership experience within a manufacturing environment or military service or five (5) years’ experience in a direct GMP, biotechnology manufacturing setting with demonstrated leadership skills

+ OR Associate degree with four (4) years of relevant leadership experience within a manufacturing environment or military service or three (3) years’ experience in a direct GMP, biotechnology manufacturing setting with demonstrated leadership skills

+ OR Bachelor’s degree with either four (4) years of relevant experience in manufacturing or military service or two (2) years’ experience in a direct GMP, biotechnology manufacturing setting with demonstrated leadership skills

Required Experience and Skills

+ At least five (5) years of relevant work experience in the vaccine and/or pharmaceutical Industry

+ At least one (1) year of experience in a leadership capacity.

+ Working knowledge of USDA/GMP Guidelines

+ Working knowledge of aseptic techniques and aseptic filling operations

+ Strong knowledge of blending, filling, freeze drying and packaging materials, principles, and operating systems

+ Proficient in Microsoft Office

+ Working knowledge of SAP (operating system)

+ Strategic and effective communication skills

+ High analytical and logical problem-solving abilities

+ Strategic and optimistic teambuilding skills that focus on mentoring and coaching

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

MSJR

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvac

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Job Posting: JC229620637

Posted On: Dec 02, 2022

Updated On: Dec 17, 2022

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